Devices and methods for treating epistaxis

ABSTRACT

The present disclosure relates to devices and methods for treating epistaxis. In some embodiments, a device for occluding epistaxis includes a first curvilinear wall, a second curvilinear wall, and a third curvilinear wall each disposed at a top portion of the device. The device has an x-axis, y-axis, and z-axis, and the top portion is relative to the y-axis. The device includes a fourth wall and a fifth wall each disposed at a bottom portion relative to the y-axis of the device. The fourth wall and the fifth wall independently are substantially straight or curvilinear. The device includes a first end including a front first end portion and a back first end portion. The first end is curvilinear corresponding to the first curvilinear wall, and the first end is disposed at an angle relative to the x-axis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 63/271,389, filed Oct. 25, 2021, which isincorporated by reference herein in its entirety.

FIELD

The present disclosure relates to devices and methods for treatingepistaxis.

BACKGROUND

Epistaxis (also referred to as a nosebleed) tends to occur frequentlywith some individuals much more than with others. Epistaxis may occurafter stress or exercise or due to dry air conditions or otherirritations of the nasal interior tissues. In particular, 90% ofepistaxis arises from the small area along the caudal septum. Bloodsupply to this area is from the Kiesselbach plexus which is composed ofsecond-order branches of the internal and external carotid arterysystems. Hemorrhage in this area is commonly referred to as anteriorepistaxis.

A typical method for treating epistaxis in a patient includespositioning the patient upright, leaning forward slightly and firmlypinching the outside of the nose with the thumb and index fingersagainst the face at a location just below the bone. Other methodsinclude applying cold packs, cauterization, nasal packing, or evensurgery. However, pinching the nose, cauterization, nasal packing, andsurgery usually cause discomfort/pain to the patient, may beineffective, and/or involve a substantial amount of time for bleeding tocease.

For example, a nasal tampon is the most common device used by providersto mitigate anterior epistaxis. The nasal tampon is inserted into thenostril by the applicator and leaves an absorbent wad/packing in thenostril. Although nasal tampons are fast effective methods in themitigation of anterior epistaxis, nasal tampons also provide painfulinsertion and removal from the nostril, potential induced trauma to thenostril, and nasal occlusion during use which inhibits a user's airway.Upon removal of a nasal tampon, the blood clot formed in the nostril canbreak and allow bleeding to continue due to adherence of the nasaltampon to the blood clot. In addition, there is no way to assess that ahemorrhage has stopped without removal of the tampon from the nostriland bleeding might still be occurring upon removal of the nasal tampon.Lastly, extensive training is needed for effective insertion and removalof the nasal tampon.

Another device used to treat epistaxis is a balloon-containing devicethat is inserted into the nasal cavity and inflated. Thisballoon-containing device has the same disadvantages of the nasaltampons, yet a balloon-containing device could exacerbate the base of askull fracture potentially displacing the fracture into the cranialvault.

Another device for treating epistaxis includes placing a “pressureinsert” between a person's gum and upper lip near the frenulum. However,such pressure inserts have proven ineffective and/or visuallyunappealing. For example, a pressure insert present only between theuser's gum and upper lip tends to not maintain its position near thefrenulum for a sufficient period of time to terminate anterior epistaxis(or the pressure insert will slide out of a user's mouth entirely). Toassist this issue, pressure inserts have been proposed that have a bitetab, a designated push surface on the bottom of the pressure insert, ora stem attached to the bottom of the insert portion. However, pressureinserts having a bite tab, push surface, or stem require action by theuser to hold the insert in place and/or adjust the position of thepressure insert, which highlights the tendency of current pressureinserts to not have an ability to maintain their position between theupper lip and the gingiva of a user and stop the anterior epistaxis,inevitably delaying the stoppage of the anterior epistaxis. In addition,pressure inserts having a bite tab, push surface, or stem are bulky insize such that the user and an outside observer (i.e., someone besidesthe user) can clearly see that a large object is present in the user'sbuccal cavity.

There is a need for improved devices for stopping epistaxis.

BRIEF SUMMARY

The present disclosure relates to devices and methods for treatingepistaxis.

In some embodiments, a device for occluding epistaxis includes one ormore apertures.

In some embodiments, a device for occluding epistaxis includes a firstcurvilinear wall, a second curvilinear wall, and a third curvilinearwall each disposed at a top portion of the device. The device has anx-axis, y-axis, and z-axis, and the top portion is relative to they-axis. The device includes a fourth wall and a fifth wall each disposedat a bottom portion relative to the y-axis of the device. The fourthwall and the fifth wall independently are substantially straight orcurvilinear. The device includes a first end including a front first endportion and a back first end portion. The first end is curvilinearcorresponding to the first curvilinear wall, and the first end isdisposed at an angle relative to the x-axis. The device includes asecond end including a front second end portion and a back second endportion. The second end is curvilinear and continuous with the thirdcurvilinear wall, and the second end disposed at an angle relative tothe x-axis. The device includes a middle portion including a frontmiddle portion and a back middle portion. The middle portion iscurvilinear and continuous with the second curvilinear wall. The deviceincludes one or more protrusions having a substantially verticalorientation relative to the y-axis. The device includes one or moreapertures disposed through the device.

In some embodiments, a device for occluding epistaxis includes a firstcurvilinear wall, a second curvilinear wall, and a third curvilinearwall each disposed at a top portion of the device. The device has anx-axis, y-axis, and z-axis. The top portion is relative to the y-axis.The device includes a fourth wall and a fifth wall each disposed at abottom portion of the device. The fourth wall and the fifth wallindependently are substantially straight or curvilinear. The deviceincludes a first end including a front first end portion and a backfirst end portion. The first end is curvilinear corresponding to thefirst curvilinear wall. The first end is disposed at an angle relativeto the x-axis. The device includes a second end including a front secondend portion and a back second end portion. The second end is curvilinearand continuous with the third curvilinear wall. The second end isdisposed at an angle relative to the x-axis. The device includes amiddle portion including a front middle portion and a back middleportion. The middle portion is curvilinear and continuous with thesecond curvilinear wall. The device includes one or more aperturesdisposed through the device.

BRIEF DESCRIPTION OF THE DRAWINGS

So that the manner in which the above recited features of the presentdisclosure can be understood in detail, a more particular description ofthe disclosure, briefly summarized above, may be had by reference toaspects, some of which are illustrated in the appended drawings. It isto be noted, however, that the appended drawings illustrate only typicalaspects of this present disclosure and are therefore not to beconsidered limiting of its scope, for the present disclosure may admitto other equally effective aspects.

FIG. 1A is a front view illustrating a device for ceasing epistaxis,according to an embodiment.

FIG. 1B is a cutaway view illustrating a portion of the device of FIG.1A, according to an embodiment.

FIG. 1C is a cutaway view illustrating a portion of the device of FIG.1A, according to an embodiment.

FIG. 1D is a cutaway view illustrating a portion of the device of FIG.1A, according to an embodiment.

FIG. 2A is a front view illustrating a device for ceasing epistaxis,according to an embodiment.

FIG. 2B is a cutaway view illustrating a portion of the device of FIG.2A, according to an embodiment.

FIG. 2C is a cutaway view illustrating a portion of the device of FIG.2A, according to an embodiment.

FIG. 2D is a cutaway view illustrating a portion of the device of FIG.2A, according to an embodiment.

FIG. 3A is a front view illustrating a device for ceasing epistaxis,according to an embodiment.

FIG. 3B is a cutaway view illustrating a portion of the device of FIG.3A, according to an embodiment.

FIG. 3C is a cutaway view illustrating a portion of the device of FIG.3A, according to an embodiment.

FIG. 3D is a cutaway view illustrating a portion of the device of FIG.3A, according to an embodiment.

FIG. 4A is a front view illustrating a device for ceasing epistaxis,according to an embodiment.

FIG. 4B is a cutaway view illustrating a portion of the device of FIG.4A, according to an embodiment.

FIG. 4C is a cutaway view illustrating a portion of the device of FIG.4A, according to an embodiment.

FIG. 4D is a cutaway view illustrating a portion of the device of FIG.4A, according to an embodiment.

FIG. 5A is a front view illustrating a device for ceasing epistaxis,according to an embodiment.

FIG. 5B is a plan view of the device of FIG. 5A, according to anembodiment.

FIG. 5C is a perspective view of the device of FIG. 5A and FIG. 5B,according to an embodiment.

FIG. 6 is a front view illustrating a device for ceasing epistaxis,according to an embodiment.

FIG. 7A is a front view illustrating a device for ceasing epistaxis,according to an embodiment.

FIG. 7B is a plan view of the device of FIG. 7A, according to anembodiment.

FIG. 7C is a perspective view of the device of FIG. 5A and FIG. 5B,according to an embodiment.

To facilitate understanding, identical reference numerals have beenused, where possible, to designate identical elements that are common tothe figures. The figures are not drawn to scale and may be simplifiedfor clarity. It is contemplated that elements and features of one aspectmay be beneficially incorporated in other aspects without furtherrecitation.

DETAILED DESCRIPTION

The present disclosure relates to devices and methods for treatingepistaxis. Devices and methods of the present disclosure provideamelioration of continual positional adjustment by the user and areinconspicuous to outside observers during use by the user. The inventorshave discovered that a device that is a material having curvilinearsidewalls, where the curvilinear sidewalls have a plurality ofprotrusions and/or apertures, provides non-invasive, painless devicesfor treating (e.g., ceasing) epistaxis. Devices and methods of thepresent disclosure do not require continual positional adjustment by theuser, and the devices are substantially or entirely inconspicuous tooutside observers during use by the user. Devices of the presentdisclosure are a simply inserted oral device which creates occlusion ofthe structures associated with anterior epistaxis, occluding the flow ofblood to the location of the hemorrhage responsible for the epistaxis.In addition, protrusions and/or apertures of devices of the presentdisclosure provide (1) the device to stay in place while occluding flowof blood to a hemorrhage and (2) substantial or complete reduction inrisk of a user inadvertently swallowing the device. In the event adevice might be swallowed, devices of the present disclosure may includeone or more apertures such that air can flow through the one or moreapertures.

In addition, devices of the present disclosure can occlude a hemorrhageto stop anterior epistaxis without nasal packing, unlike a nasal tampon,leaving the nostril free from obstruction. Insertion and removal ofdevices of the present disclosure is painless, providing less fear for auser. In addition, risk of opening a clot upon removal of the device issubstantially less (e.g., eliminated), as compared to nasal tampons andballoon-like devices. In addition, devices of the present disclosure donot require substantial training on how to use the devices, as comparedto nasal tampons and balloon-like devices. In addition, devices of thepresent disclosure are small (e.g., as compared to devices having a stemor a bite tab) making the devices easy to transport without taking upsubstantial space (e.g., the devices can be transported in a user'spocket).

In some embodiments which can be combined with other embodiments, adevice for occluding epistaxis includes one or more apertures.

In some embodiments, a device for occluding epistaxis includes a firstcurvilinear wall, a second curvilinear wall, and a third curvilinearwall each disposed at a top portion of the device. The device has anx-axis, y-axis, and z-axis, and the top portion is relative to they-axis. The device includes a fourth wall and a fifth wall each disposedat a bottom portion relative to the y-axis of the device. The fourthwall and the fifth wall independently are substantially straight orcurvilinear. The device includes a first end including a front first endportion and a back first end portion. The first end is curvilinearcorresponding to the first curvilinear wall, and the first end isdisposed at an angle relative to the x-axis. The device includes asecond end including a front second end portion and a back second endportion. The second end is curvilinear and continuous with the thirdcurvilinear wall, and the second end disposed at an angle relative tothe x-axis. The device includes a middle portion including a frontmiddle portion and a back middle portion. The middle portion iscurvilinear and continuous with the second curvilinear wall. The deviceincludes one or more protrusions having a substantially verticalorientation relative to the y-axis. The device includes one or moreapertures disposed through the device.

In some embodiments, a device for occluding epistaxis includes a firstcurvilinear wall, a second curvilinear wall, and a third curvilinearwall each disposed at a top portion of the device. The device has anx-axis, y-axis, and z-axis. The top portion is relative to the y-axis.The device includes a fourth wall and a fifth wall each disposed at abottom portion of the device. The fourth wall and the fifth wallindependently are substantially straight or curvilinear. The deviceincludes a first end including a front first end portion and a backfirst end portion. The first end is curvilinear corresponding to thefirst curvilinear wall. The first end is disposed at an angle relativeto the x-axis. The device includes a second end including a front secondend portion and a back second end portion. The second end is curvilinearand continuous with the third curvilinear wall. The second end isdisposed at an angle relative to the x-axis. The device includes amiddle portion including a front middle portion and a back middleportion. The middle portion is curvilinear and continuous with thesecond curvilinear wall. The device includes one or more aperturesdisposed through the device.

Devices

Devices of the present disclosure, when placed between the upper lip andthe gingiva of a user, are configured to occlude blood to a hemorrhageby applying pressure to the user's superior labial artery, theKiesselbach plexus, and/or the greater palatine artery. By applyinggentle pressure to this area, the blood is occluded at the hemorrhage.

In some embodiments, a device is a material having curvilinearsidewalls. For example, the curvilinear sidewalls might not behorizontally extending, but instead the device has a first end andsecond end where the first end and/or second end are disposed at anangle relative to a horizontal axis. For example, the first end canextend from a first curvilinear portion in a direction that is notparallel with the horizontal axis and is not orthogonal to the verticalaxis. The second end can extend from a second curvilinear portion in adirection that is not parallel with the horizontal axis and is notorthogonal to the vertical axis.

A device has a gap portion shaped to fit around (e.g., nest with) auser's frenulum such that the device does not interfere with thefrenulum but nonetheless provides amelioration of epistaxis by occludingblood to a hemorrhage by applying pressure to the user's superior labialartery, the Kiesselbach plexus, and/or the greater palatine artery.

In some embodiments, the curvilinear sidewalls have a plurality ofprotrusions and/or one or more apertures such that air can flow throughthe one or more apertures.

FIG. 1A is a front view of a device 100. Device 100 is aserpentine-shaped material having curvilinear sidewalls 102 a, 102 b,102 c, 102 d, 102 e, and 102 f. Curvilinear sidewalls 102 a and 102 bcan apply pressure during use to the user's superior labial artery, theKiesselbach plexus, and/or the greater palatine artery.

The curvilinear sidewalls 102 a-102 f are not horizontally extending,but instead the device 100 has a first end 104 and second end 106 wherethe first end 104 and the second end 106 are disposed at an anglerelative to a horizontal axis 108.

For example, the first end 104 can extend from a first curvilinearportion (e.g., apex point 126 of sidewall 102 a to valley point 124and/or to end cap 120) in a direction that is not parallel with thehorizontal axis 108 and is not orthogonal to the vertical axis 110. Thesecond end 106 can extend from a second curvilinear portion (e.g., apexpoint 128 of sidewall 102 b to valley point 124 and/or to end cap 122)in a direction that is not parallel with the horizontal axis 108 and isnot orthogonal to the vertical axis 110.

Device 100 has a front first end portion 114, a front second end portion118, and a front middle portion 116. The front first end portion 114 hasa curvilinear shape corresponding to curvilinear sidewall 102 a andcurvilinear sidewall 102 e. A rear first end portion (not shown) isdisposed on a side opposite of front first end portion 114, and the rearfirst end portion has a curvilinear shape corresponding to curvilinearsidewall 102 a and curvilinear sidewall 102 e.

The front second end portion 118 has a curvilinear shape correspondingto curvilinear sidewall 102 b and curvilinear sidewall 102 c. A rearsecond end portion (not shown) is disposed on a side opposite of frontsecond end portion 118, and the rear first end portion has a curvilinearshape corresponding to curvilinear sidewall 102 b and curvilinearsidewall 102 c.

The front middle portion 116 has a curvilinear shape corresponding tocurvilinear sidewall 102 d and curvilinear sidewall 102 f. A rear middleportion (not shown) is disposed on a side opposite of front middleportion 116, and the rear middle portion has a curvilinear shapecorresponding to curvilinear sidewall 102 a and curvilinear sidewall 102e.

Device 100 has a gap portion 112 shaped to fit around (e.g., nest with)a user's frenulum such that the device does not interfere with thefrenulum and the device provides occlusion of a hemorrhage promotingepistaxis during use. Gap portion 112 has a valley point 124 (ofsidewall 102 f) provided by the descent of sidewall 102 a from apexpoint 126 toward horizontal axis 108 and provided by the descent ofsidewall 102 b from apex point 128 toward horizontal axis 108.

Sidewall 102 e has a valley point 132 disposed opposite the apex point126 of sidewall 102 a. Sidewall 102 d has an apex point 130 disposedopposite valley point 124 of sidewall 102 f. Sidewall 102 c has a valleypoint 134 disposed opposite apex point 128 of sidewall 102 b. In someembodiments, valley point 134 is aligned with valley point 132 andvalley point 134 along horizontal axis 108.

Device 100 has a first end cap 120 and a second end cap 122. First endcap 120 and second end cap 122 are independently selected fromdome-shaped (as shown in FIG. 1A), pointed (e.g., conical ending in apoint), or tapered. However, other suitable shapes for the first end cap120 and second end cap 122 are contemplated.

In some embodiments which can be combined with other embodiments, device100 has a width (W) (e.g., linear distance from first end cap 120 tosecond end cap 122) of about 50 millimeters (mm) to about 70 mm, such asabout 55 mm to about 65 mm, such as about 57 mm to about 60 mm, such asabout 58 mm. In some embodiments which can be combined with otherembodiments, device 100 has a height (H) (e.g., vertical distance frompeak points 126 and 128 to peak point 130) of about 10 mm to about 18mm, such as about 12 mm to about 16 mm, such as about 13 mm to about 15mm, such as about 14 mm.

Alternatively, device 100 has a width (W) (e.g., linear distance fromfirst end cap 120 to second end cap 122) of about 25 millimeters (mm) toabout 50 mm, such as about 28 mm to about 40 mm, such as about 29 mm toabout 31 mm, alternatively about 36 mm to about 38 mm. In someembodiments, device 100 has a height (H) (e.g., vertical distance frompeak points 126 and 128 to peak point 130) of about 4 mm to about 15 mm,such as about 4 mm to about 7 mm, alternatively about 9 mm to about 11mm, such as about 10 mm.

FIG. 1B is a cross-sectional view of first end portion 114. Thecross-sectional view illustrates first end portion 114 has asubstantially circular shape 150. FIG. 1C is a cross-sectional view ofmiddle portion 116. The cross-sectional view illustrates middle portion116 having a substantially circular shape 160. FIG. 1D is across-sectional view of second end portion 118. The cross-sectional viewillustrates second end portion 118 has a substantially circular shape170. First end portion 114, middle portion 116, and second end portion118 can independently have a diameter (D) of about 4 mm to about 8 mm,such as about 5 mm to about 7 mm, such as about 5.5 mm to about 6.5 mm,such as about 6 mm. Alternatively, first end portion 114, middle portion116, and second end portion 118 can independently have a diameter (D) ofabout 1 mm to about 5 mm, such as about 1.5 mm to about 3.5 mm, such asabout 2 mm to about 3 mm, such as about 2.5 mm. In some embodiments, thediameter of each of the first end portion 314, middle portion 316, andsecond end portion 318 is substantially the same.

Taken together, a substantially circular shape of first end portion 114,middle portion 116, and second end portion 118 provides a device 100having a substantially tubular (e.g., curvilinear tubular, e.g.,curvilinear filled/solid tubular) shape. For example, device 100 has 90%or greater of portions having a substantially circular diameter of about4 mm to about 8 mm, such as about 5 mm to about 7 mm, such as about 5.5mm to about 6.5 mm, such as about 6 mm.

Device 100 may be substantially straight (e.g., from a top view ofdevice 100 relative to (e.g., parallel with) horizontal axis 108(x-axis)) and be allowed to curve rearward upon insertion into a user'sbuccal cavity between the upper gums and upper lip. Alternatively,device 100 may be molded to have a rearward curvature (e.g., from a topview of device 100 relative to (e.g., is not parallel to) horizontalaxis 108 (x-axis)) such that device 100 even when not being used curvesrearward to conform with a user's buccal cavity when in use.

In some embodiments which can be combined with other embodiments, thecurvilinear sidewalls and/or end caps have a plurality of protrusions.As shown in FIG. 2A, device 200 of FIG. 2A has the same design as device100 of FIG. 1A except device 200 of FIG. 2A further includes a pluralityof protrusions 202. The protrusions 202 can have a substantiallyvertical orientation (e.g., perpendicular to a surface of the device 200and/or the horizontal axis 108 of the device 200. Nonetheless, one ormore of the protrusions 202 can be disposed at an angle relative tovertical axis 110, such as an angle of about 1° to about 45°, such asabout 1° to about 30°, such as about 1° to about 10°, such as about 3°to about 5°, alternatively about −1° to about −45°, such as about −1° toabout −30°, such as about −1° to about −10°, such as about −3° to about−5° A protrusion 202 that extends from peak point 126 toward valleypoint 132 is substantially parallel with vertical axis 110, and aprotrusion 202 that extends from peak 128 toward valley point 134 issubstantially parallel with vertical axis 110. Protrusions 202 can havea height “h” (a vertical distance extending from a peak to a valley ofthe protrusion). For example, protrusions can have an average height ofabout 2 mm to about 4 mm. Protrusions can circumscribe the device 200or, as shown in FIGS. 2A-2D, can have a first end and second end and canhave a length “1” (along the surface of the device) of about 6 mm toabout 10 mm. In some embodiments, length “1” is slightly less than theaverage diameter “D” of device 200. In some embodiments which can becombined with other embodiments, a plurality of protrusions of a deviceof the present disclosure can include one protrusion to about 50protrusions, such as about 2 protrusions to about 25 protrusions, suchas about 10 protrusions to about 20 protrusions. However, more or lessprotrusions is also contemplated.

In some embodiments, the relative angulation of portions of protrusions202 of device 200 can be utilized to promote a grip of the protrusionsto a user's lip and/or gums during use. For example, a first portion 204of device 200 can be such that protrusions 202 are angulated from peakpoint 126 toward end cap 120. Meanwhile, a second portion 206 can besuch that protrusions 202 are angulated from peak point 126 toward peakpoint 130. In addition, a third portion 208 can be such that protrusions202 are angulated from peak point 128 toward peak point 130. A fourthportion 210 can be such that protrusions 202 are angulated from peakpoint 128 toward end cap 122. It has been discovered that angulation ofprotrusions as shown in device 200 can promote a grip of the protrusionsto a user's lip and/or gums during use.

FIG. 3A is a front view of a device 300. Device 300 is a curve-shapedmaterial having sidewalls 302 a, 302 b, 302 c, 302 d, 302 e, and 302 f.Sidewalls 302 a and 302 b can apply pressure during use to the user'ssuperior labial artery, the Kiesselbach plexus, and/or the greaterpalatine artery. While the device 200 is described as having multiplesidewalls, it is to be understood that the device 200 is a curvilinearshape that can have sidewalls continuous with one another. Theterminology used herein is employed to facilitate explanation of theviews shown.

Sidewalls 302 d and 302 f are curvilinear sidewalls. The sidewalls 302 dand 302 f are not horizontally extending. The device 300 has a first end304 and second end 306 where the first end 304 and the second end 306are disposed at an upward angle relative to a horizontal axis 308. Forexample, the first end 304 can extend from a middle point of device 300(e.g., valley point 324) in an upward direction (at an angle) tosidewall 302 a (e.g., peak point 326), and the upward direction is notparallel with the horizontal axis 308 and is not orthogonal to thevertical axis 310. The second end 308 can extend can extend from amiddle point of device 300 (e.g., valley point 324) in an upwarddirection (at an angle) to sidewall 302 b (e.g., peak point 328), andthe upward direction is not parallel with the horizontal axis 308 and isnot orthogonal to the vertical axis 310.

Device 300 has a front first end portion 314, a front second end portion318, and a front middle portion 316. The front middle portion 316 has acurvilinear shape corresponding to curvilinear sidewall 302 d andcurvilinear sidewall 302 f. A rear middle portion (not shown) isdisposed on a side opposite of front middle portion 316, and the rearmiddle portion has a curvilinear shape corresponding to curvilinearsidewall 302 a and curvilinear sidewall 302 e.

Device 300 has a gap portion 312 shaped to fit around (e.g., nest with)a user's frenulum such that the device does not interfere with thefrenulum and the device provides amelioration of epistaxis. Gap portion312 has a valley point 324 (of sidewall 302 f) provided by the descentof sidewall 302 a from apex point 326 toward horizontal axis 308 andprovided by the descent of sidewall 302 b from apex point 328 towardhorizontal axis 308.

Sidewall 302 e has an end point 332 disposed opposite the apex point 326of sidewall 302 a. Sidewall 302 d has an apex point 330 disposedopposite valley point 324 of sidewall 302 f. Sidewall 302 c has an endpoint 334 disposed opposite apex point 328 of sidewall 302 b. In someembodiments, valley point 124 is aligned with end point 332 and endpoint 334 along horizontal axis 308.

Device 300 has a first end cap 320 and a second end cap 322. First endcap 320 is coupled with the front first end portion 314 at apex point326 and end point 332 (and is coupled with the rear first end portion(not shown)). Second end cap 322 is coupled with the front second endportion 318 at apex point 328 and end point 334 (and is coupled with therear second end portion (not shown)). In some embodiments which can becombined with other embodiments, a first end cap 320 and a second endcap 322 of a device of the present disclosure are independently selectedfrom dome-shaped (as shown in FIG. 3A), pointed (e.g., conical ending ina point), or tapered. However, other shapes are also contemplated.

In some embodiments which can be combined with other embodiments, device300 has a width (W) (e.g., a linear distance from first end cap 320 tosecond end cap 322) of about 50 millimeters (mm) to about 70 mm, such asabout 55 mm to about 65 mm, such as about 57 mm to about 60 mm, such asabout 58 mm. In some embodiments which can be combined with otherembodiments, device 300 has a height (H) (e.g., vertical distance frompeak points 326 and 328 to peak point 330) of about 10 mm to about 18mm, such as about 12 mm to about 16 mm, such as about 13 mm to about 15mm, such as about 14 mm.

Alternatively, device 300 has a width (W) (e.g., linear distance fromfirst end cap 320 to second end cap 322) of about 25 millimeters (mm) toabout 50 mm, such as about 28 mm to about 40 mm, such as about 29 mm toabout 31 mm, alternatively about 36 mm to about 38 mm. In someembodiments, device 300 has a height (H) (e.g., vertical distance frompeak points 326 and 328 to peak point 330) of about 4 mm to about 15 mm,such as about 4 mm to about 7 mm, alternatively about 9 mm to about 11mm, such as about 10 mm.

FIG. 3B is a cross-sectional view of first end portion 314. Thecross-sectional view illustrates first end portion 314 has asubstantially circular shape 350. FIG. 3C is a cross-sectional view ofmiddle portion 316. The cross-sectional view illustrates middle portion316 has a substantially circular shape 360. FIG. 3D is a cross-sectionalview of second end portion 318. The cross-sectional view illustratessecond end portion 318 has a substantially circular shape 370. First endportion 314, middle portion 316, and second end portion 318 canindependently have a diameter (D) of about 4 mm to about 8 mm, such asabout 5 mm to about 7 mm, such as about 5.5 mm to about 6.5 mm, such asabout 6 mm. Alternatively, first end portion 314, middle portion 316,and second end portion 318 can independently have a diameter (D) ofabout 1 mm to about 5 mm, such as about 1.5 mm to about 3.5 mm, such asabout 2 mm to about 3 mm, such as about 2.5 mm. In some embodiments, thediameter of each of the first end portion 314, middle portion 316, andsecond end portion 318 is substantially the same.

Taken together, a substantially circular shape of first end portion 314,middle portion 316, and second end portion 318 provides a device 300having a substantially tubular (e.g., curvilinear tubular, e.g.,curvilinear filled/solid tubular) shape. For example, device 300 has 90%or greater of portions having a substantially circular diameter of about4 mm to about 8 mm, such as about 5 mm to about 7 mm, such as about 5.5mm to about 6.5 mm, such as about 6 mm.

Device 300 may be substantially straight (e.g., from a top view ofdevice 300 relative to (e.g., parallel with) horizontal axis 308(x-axis)) and be allowed to curve rearward upon insertion into a user'sbuccal cavity between the upper gums and upper lip. Alternatively,device 300 may be molded to have a rearward curvature (e.g., from a topview of device 300 relative to (e.g., is not parallel with) horizontalaxis 308 (x-axis)).

In some embodiments which can be combined with other embodiments, thecurvilinear sidewalls and/or end caps have a plurality of protrusions.As shown in FIG. 4A, device 400 of FIG. 4A has the same design as device300 of FIG. 3A except device 300 of FIG. 3A further includes a pluralityof protrusions 402. The protrusions 402 can have a substantiallyvertical orientation. Nonetheless, one or more of the protrusions 402can be disposed at an angle relative to vertical axis 310, such as anangle of about 1° to about 45°, such as about 1° to about 30°, such asabout 1° to about 10°, such as about 3° to about 5°, alternatively about−1° to about −45°, such as about −1° to about −30°, such as about −1° toabout −10°, such as about −3° to about −5°. Protrusions 402 can have aheight “h” (a vertical distance extending from a peak to a valley of theprotrusion). For example, protrusions can have an average height ofabout 2 mm to about 5 mm. Protrusions can circumscribe the device 400or, as shown in FIGS. 4A-4D, protrusions can have a first end and secondend and can have a length “1” of about 2 mm to about 5 mm. In someembodiments, length “1” is slightly less than the average diameter “D”of device 400. In some embodiments, a plurality of protrusions of adevice of the present disclosure can include one protrusion to about 50protrusions, such as about 2 protrusions to about 25 protrusions, suchas about 10 protrusions to about 20 protrusions. However, fewer or moreprotrusions is also contemplated.

In some embodiments, the relative angulation of portions of protrusions402 of device 400 can be utilized to promote a grip of the protrusionsto a user's lip and/or gums during use. For example, a first portion 404of device 400 can be such that protrusions 402 are angulated from peakpoint 326 toward end cap 320. Meanwhile, a second portion 406 can besuch that protrusions 402 are angulated from peak point 326 toward peakpoint 330. In addition, a third portion 408 can be such that protrusions402 are angulated from peak point 328 toward peak point 330. A fourthportion 410 can be such that protrusions 402 are angulated from peakpoint 328 toward end cap 322. It has been discovered that angulation ofprotrusions as shown in device 400 can promote a grip of the protrusionsto a user's lip and/or gums during use.

In some embodiments, devices of the present disclosure have one or moreapertures such that air can flow through the one or more apertures. Adevice can have one or more apertures alternatively or in addition to aplurality of protrusions.

FIG. 5A is a front view of a device 500. Device 500 has curvilinearsidewalls 502 a, 502 b, 502 c, 502 d, and 502 e. As shown in FIG. 5A,sidewalls 502 d and 502 e have less curvature than sidewalls 502 a, 502b, and 502 c. In some embodiments, sidewalls 502 d and 502 e aresubstantially straight. Curvilinear sidewalls 502 a and 502 b can applypressure during use to the user's superior labial artery, theKiesselbach plexus, and/or the greater palatine artery. While the device500 is described as having multiple sidewalls, it is to be understoodthat the device 500 is a curvilinear shape that can have sidewallscontinuous with one another. The terminology used herein is employed tofacilitate explanation of the views shown. In some embodiments, a ratioof the length of curvilinear top side (e.g., sidewalls 502 a+502 b+502 cextending from 520 to 522) to the length of the bottom side (e.g.,sidewalls 502 d+502 e extending from 520 to 522) is from about 1 toabout 2, such as about 1.2 to about 1.5.

The curvilinear sidewalls 502 a-502 f are not horizontally extending,but instead the device 500 has a first end 504 and second end 506 wherethe first end 504 and the second end 506 are disposed at an anglerelative to a horizontal axis 508. For example, the first end 504 canextend from a first curvilinear portion (e.g., apex point 526 ofsidewall 502 a to valley point 524 and/or to end cap 520) in a directionthat is not parallel with the horizontal axis 508 and is not orthogonalto the vertical axis 510. The second end 506 can extend from a secondcurvilinear portion (e.g., apex point 528 of sidewall 502 b to valleypoint 524 and/or to end cap 522) in a direction that is not parallelwith the horizontal axis 508 and is not orthogonal to the vertical axis510.

Device 500 has a front first end portion 514, a front second end portion518, and a front middle portion 516. The front first end portion 514 hasa curvilinear shape corresponding to curvilinear sidewall 502 a andcurvilinear sidewall 502 d. A rear first end portion (not shown) isdisposed on a side opposite of front first end portion 514, and the rearfirst end portion has a curvilinear shape corresponding to curvilinearsidewall 502 a and curvilinear sidewall 502 d.

The front second end portion 518 has a curvilinear shape correspondingto curvilinear sidewall 502 b and curvilinear sidewall 502 e. A rearsecond end portion (not shown) is disposed on a side opposite of frontsecond end portion 518, and the rear first end portion has a curvilinearshape corresponding to curvilinear sidewall 502 b and curvilinearsidewall 502 e.

The front middle portion 516 has a curvilinear shape corresponding tocurvilinear sidewall 502 c (having valley point 524) and valley point530 at the intersection of sidewall 502 d with sidewall 502 e. A rearmiddle portion (not shown) is disposed on a side opposite of frontmiddle portion 516, and the rear middle portion has a curvilinear shapecorresponding to curvilinear sidewall 502 c (having valley point 524)and valley point 530 at the intersection of sidewall 502 d with sidewall502 e.

Device 500 has a gap portion 512 shaped to fit around (e.g., nest with)a user's frenulum such that the device does not interfere with thefrenulum and the device provides occlusion of a hemorrhage promotingepistaxis during use. Gap portion 512 has the valley point 524 (ofsidewall 502 c) provided by the descent of sidewall 502 a from apexpoint 526 toward horizontal axis 508 and provided by the descent ofsidewall 502 b from apex point 528 toward horizontal axis 508.

Sidewall 502 d has a valley point 532 disposed opposite the apex point526 of sidewall 502 a. In addition, valley point 530 is disposedopposite valley point 524 of sidewall 502 c. Sidewall 502 e has a valleypoint 534 disposed opposite apex point 528 of sidewall 502 b.

Device 500 has a first end cap 520 and a second end cap 522. In someembodiments, a first end cap 520 and a second end cap 522 of a device ofthe present disclosure are independently selected from dome-shaped,pointed (e.g., conical ending in a point), wing-tipped (as shown in FIG.5A), or tapered. However, other shapes are also contemplated.

Device 500 further includes a plurality of protrusions 502. Theprotrusions 502 can have a substantially vertical orientation.Nonetheless, one or more of the protrusions 502 can be disposed at anangle relative to vertical axis 510, such as an angle of about 1° toabout 45°, such as about 1° to about 30°, such as about 1° to about 10°,such as about 3° to about 5°, alternatively about −1° to about −45°,such as about −1° to about −30°, such as about −1° to about −10°, suchas about −3° to about −5°. A protrusion 502 that extends from peak point526 to valley point 532 is substantially parallel with vertical axis510, and a protrusion 502 that extends from peak 528 to valley point 534is substantially parallel with vertical axis 510. Protrusions 502 canhave a height “h” (a vertical distance extending from a peak to a valleyof the protrusion). For example, protrusions can have an average heightof about 2 mm to about 4 mm. Protrusions can circumscribe the device 500or, as partially shown in FIG. 5B, can have a first end and second endand can have a length “1” of about 6 mm to about 10 mm. In someembodiments, length “1” is slightly less than the height (H) of device500. In some embodiments, a plurality of protrusions of a device of thepresent disclosure can include one protrusion to about 50 protrusions,such as about 2 protrusions to about 25 protrusions, such as about 10protrusions to about 20 protrusions. However, fewer or more protrusionsare also contemplated.

In some embodiments, the relative angulation of portions of protrusions502 of device 500 can be utilized to promote a grip of the protrusionsto a user's lip and/or gums during use. For example, a first portion 560of device 500 can be such that protrusions 502 are angulated from peakpoint 526 toward end cap 520. Meanwhile, a second portion 562 can besuch that protrusions 502 are angulated from peak point 526 towardvalley point 530. In addition, a third portion 564 can be such thatprotrusions 502 are angulated from peak point 528 toward valley point530. A fourth portion 566 can be such that protrusions 502 are angulatedfrom peak point 528 toward end cap 522. It has been discovered thatangulation of protrusions as shown in device 500 can promote a grip ofthe protrusions to a user's lip and/or gums during use.

Device 500 further includes a plurality of apertures 540. As shown inFIG. 5A, the plurality of apertures 540 is arranged in a row across alower portion device 500. Alternatively, a plurality of apertures can bearranged in any number of geometries, such as multiple rows arrangedhorizontally, vertically, and/or diagonally across device 500. Apertures540 individually have a circular shape. However, other shapes are alsocontemplated. In some embodiments, apertures (of a plurality ofapertures) have a shape selected from circular, square, rectangular,conical, star, or combination(s) thereof. In addition, as shown in FIG.5A, device 500 has sixteen apertures. Alternatively, a plurality ofapertures of a device of the present disclosure can include one apertureto about 50 apertures, such as about 2 apertures to about 25 apertures,such as about 10 apertures to about 20 apertures. For example, anaperture traverses the entire thickness of device 500 and the aperturecan have a width “w” (e.g., as seen from the view of FIG. 5A) of nowider than about 1 mm, such as about 0.1 mm to about 1 mm, such as about0.3 mm to about 0.7 mm. However, other sizes are also contemplated.

In some embodiments which can be combined with other embodiments, device500 has a width (W) (e.g., linear distance from first end cap 520 tosecond end cap 522) of about 50 millimeters (mm) to about 70 mm, such asabout 55 mm to about 65 mm, such as about 57 mm to about 60 mm, such asabout 58 mm. In some embodiments which can be combined with otherembodiments, device 500 has a height (H) (e.g., vertical distance frompeak points 526 and 528 to an end cap) of about 10 mm to about 18 mm,such as about 12 mm to about 16 mm, such as about 13 mm to about 15 mm,such as about 14 mm.

Alternatively, device 500 has a width (W) (e.g., linear distance fromfirst end cap 520 to second end cap 522) of about 25 millimeters (mm) toabout 50 mm, such as about 28 mm to about 40 mm, such as about 29 mm toabout 31 mm, alternatively about 36 mm to about 38 mm. In someembodiments, device 500 has a height (H) (e.g., vertical distance frompeak points 526 and 528 to an end cap) of about 4 mm to about 15 mm,such as about 4 mm to about 7 mm, alternatively about 9 mm to about 11mm, such as about 10 mm.

FIG. 5B is a plan view of device 500 of FIG. 5A. As shown in FIG. 5B,device 500 has a curvature (as viewed from the plan view), whichadvantageously allows device 500 to conform to a user's gums during use.Device 500 has a first lobe 570 and a second lobe 572. During use ofdevice 500, first lobe 570 and second lobe 572 can apply pressure to theuser's superior labial artery, the Kiesselbach plexus, and/or thegreater palatine artery. First lobe 570 and second lobe 572 canindependently have a thickness “t” of about 2 mm to about 4 mm,alternatively about 1 mm to about 3 mm. In addition, a lower portion ofdevice 500 (e.g., the lower portion of device 500 having the pluralityof apertures 540 shown in FIG. 5A) disposed below first lobe 570 andsecond lobe 572 can have a thickness that is less than the thickness “t”of first lobe 570 and/or second lobe 572. For example, a lower portionof device 500 can have an average thickness of about 1 mm to about 3 mm,alternatively about 0.5 mm to about 2 mm. The thickness of the lowerportion of device 500 can be the same as the distance an aperturetraverses through device 500. Accordingly, in some embodiments, it canbe advantageous to provide apertures for a device of the presentdisclosure in locations of the device that are not as thick as the lobes(e.g., lobes 570 and/or 572), improving air flow through the device inthe event the device might be swallowed during use. In addition, athickness “t” of the lobes (e.g., lobes 570 and/or 572) that is greaterthan a thickness of a lower portion of the device (e.g., device 500)provides an opportunity for a user's lip to partially circumscribedevice 500 during use allowing the lip to squeeze the device, furtherimproving the grip on the device between the gums and lip of the user.

FIG. 6 is a front view of a device 600. Device 600 is substantially thesame as device 500 of FIGS. 5A-5B except the plurality of apertures 540of device 600 is oriented vertically in a row. In addition, device 600has two apertures 540 (instead of the sixteen apertures 540 of device500).

In some embodiments which can be combined with other embodiments,devices of the present disclosure have one or more apertures such thatair can flow through the one or more apertures, and the apertures aresubstantially vertical (e.g., commensurate with the y-axis) andelongated. FIG. 7A is a front view of a device 700. Device 700 hascurvilinear sidewalls 702 a, 702 b, 702 c, 702 d, and 702 e. As shown inFIG. 7A, sidewalls 702 d and 702 e have less curvature than sidewalls702 a, 702 b, and 702 c. In some embodiments, sidewalls 702 d and 702 eare substantially straight. Curvilinear sidewalls 702 a and 702 b canapply pressure during use to the user's superior labial artery, theKiesselbach plexus, and/or the greater palatine artery. While the device700 is described as having multiple sidewalls, it is to be understoodthat the device 700 is a curvilinear shape that can have sidewallscontinuous with one another. The terminology used herein is employed tofacilitate explanation of the views shown. In some embodiments, a ratioof the length of curvilinear top side (e.g., sidewalls 702 a+702 b+702 cextending from 720 to 722) to the length of the bottom side (e.g.,sidewalls 702 d+702 e extending from 720 to 722) is from about 1 toabout 2, such as about 1.2 to about 1.5.

The curvilinear sidewalls 702 a-702 f are not horizontally extending,but instead the device 700 has a first end 704 and second end 706 wherethe first end 704 and the second end 706 are disposed at an anglerelative to a horizontal axis 708. For example, the first end 704 canextend from a first curvilinear portion (e.g., apex point 726 ofsidewall 702 a to valley point 724 and/or to end cap 720) in a directionthat is not parallel with the horizontal axis 708 and is not orthogonalto the vertical axis 710. The second end 706 can extend from a secondcurvilinear portion (e.g., apex point 728 of sidewall 702 b to valleypoint 724 and/or to end cap 722) in a direction that is not parallelwith the horizontal axis 708 and is not orthogonal to the vertical axis710.

Device 700 has a front first end portion 714, a front second end portion718, and a front middle portion 716. The front first end portion 714 hasa curvilinear shape corresponding to curvilinear sidewall 702 a andcurvilinear sidewall 702 d. A rear first end portion (not shown) isdisposed on a side opposite of front first end portion 714, and the rearfirst end portion has a curvilinear shape corresponding to curvilinearsidewall 702 a and curvilinear sidewall 702 d.

The front second end portion 718 has a curvilinear shape correspondingto curvilinear sidewall 702 b and curvilinear sidewall 702 e. A rearsecond end portion (not shown) is disposed on a side opposite of frontsecond end portion 718, and the rear first end portion has a curvilinearshape corresponding to curvilinear sidewall 702 b and curvilinearsidewall 702 e.

The front middle portion 716 has a curvilinear shape corresponding tocurvilinear sidewall 702 c (having valley point 724) and valley point730 at the intersection of sidewall 702 d with sidewall 702 e. A rearmiddle portion (not shown) is disposed on a side opposite of frontmiddle portion 716, and the rear middle portion has a curvilinear shapecorresponding to curvilinear sidewall 702 c (having valley point 724)and valley point 730 at the intersection of sidewall 702 d with sidewall702 e.

Device 700 has a gap portion 712 shaped to fit around (e.g., nest with)a user's frenulum such that the device does not interfere with thefrenulum and the device provides occlusion of a hemorrhage promotingepistaxis during use. Gap portion 712 has the valley point 724 (ofsidewall 702 c) provided by the descent of sidewall 702 a from apexpoint 726 toward horizontal axis 708 and provided by the descent ofsidewall 702 b from apex point 728 toward horizontal axis 708.

Sidewall 702 d has a valley point 732 disposed opposite the apex point726 of sidewall 702 a. In addition, valley point 730 is disposedopposite valley point 724 of sidewall 702 c. Sidewall 702 e has a valleypoint 734 disposed opposite apex point 728 of sidewall 702 b.

Device 700 has a first end cap 720 and a second end cap 722. In someembodiments, a first end cap 720 and a second end cap 722 of a device ofthe present disclosure are independently selected from dome-shaped,pointed (e.g., conical ending in a point), wing-tipped (as shown in FIG.7A), or tapered. However, other shapes are also contemplated.

Device 700 further includes a plurality of apertures 740. The apertures740 can have a substantially vertical orientation and be elongated(e.g., vertically elongated as shown in FIG. 7A). Nonetheless, one ormore of the apertures 740 can be disposed at an angle relative tovertical axis 710, such as an angle of about 1° to about 45°, such asabout 1° to about 30°, such as about 1° to about 10°, such as about 3°to about 5°, alternatively about −1° to about −45°, such as about −1° toabout −30°, such as about −1° to about −10°, such as about −3° to about−5°. An aperture 740 that extends from peak point 726 to valley point732 is substantially parallel with vertical axis 710, and an aperture740 that extends from peak 728 to valley point 734 is substantiallyparallel with vertical axis 710. An aperture has a first end toward atop portion of the device and second end toward a lower portion of thedevice. An aperture can have a length “1” (distance between the firstend and the second end of the aperture) of about 0.1 mm to about 40 mm,such as about 5 mm to about 30 mm, such as about 5 mm to about 20 mm,such as about 5 mm to about 10 mm. In some embodiments, length “1” isslightly less than the height (H) of device 700. In some embodiments, aplurality of protrusions of a device of the present disclosure caninclude one protrusion to about 50 protrusions, such as about 2protrusions to about 25 protrusions, such as about 10 protrusions toabout 20 protrusions. However, fewer or more protrusions are alsocontemplated.

In some embodiments, the relative angulation of portions of apertures740 of device 700 can be utilized to provide a corresponding angulationof the remaining material and the apertures of the device (e.g., theremaining material and the apertures per se) to promote a grip of theremaining material to a user's lip and/or gums during use. For example,a first portion 760 of device 700 can be such that apertures 740 areangulated from peak point 726 toward end cap 720. Meanwhile, a secondportion 762 can be such that apertures 740 are angulated from peak point726 toward valley point 730. In addition, a third portion 764 can besuch that apertures 740 are angulated from peak point 728 toward valleypoint 730. A fourth portion 766 can be such that apertures 740 areangulated from peak point 728 toward end cap 722. It has been discoveredthat angulation of apertures 740 as shown in device 700 can promote agrip of the remaining material and apertures to a user's lip and/or gumsduring use.

As shown in FIG. 7A, device 700 has twenty three apertures.Alternatively, a plurality of apertures of a device of the presentdisclosure can include one aperture to about 50 apertures, such as about2 apertures to about 25 apertures, such as about 10 apertures to about20 apertures. Apertures of the present disclosure can have a size. Forexample, an aperture traverses the entire thickness of device 700 andthe aperture can have a width “w” (e.g., as seen from the view of FIG.7A) of no wider than about 1 mm, such as about 0.1 mm to about 1 mm,such as about 0.3 mm to about 0.7 mm.

In some embodiments, device 700 has a width (W) (e.g., linear distancefrom first end cap 720 to second end cap 722) of about 50 millimeters(mm) to about 70 mm, such as about 55 mm to about 65 mm, such as about57 mm to about 60 mm, such as about 58 mm. In some embodiments, device700 has a height (H) (e.g., vertical distance from peak points 726 and728 to an end cap) of about 10 mm to about 18 mm, such as about 12 mm toabout 16 mm, such as about 13 mm to about 15 mm, such as about 14 mm.

Alternatively, device 700 has a width (W) (e.g., linear distance fromfirst end cap 720 to second end cap 722) of about 25 millimeters (mm) toabout 50 mm, such as about 28 mm to about 40 mm, such as about 29 mm toabout 31 mm, alternatively about 36 mm to about 38 mm. In someembodiments, device 700 has a height (H) (e.g., vertical distance frompeak points 726 and 728 to an end cap) of about 4 mm to about 15 mm,such as about 4 mm to about 7 mm, alternatively about 9 mm to about 11mm, such as about 10 mm.

FIG. 7B is a plan view of device 700 of FIG. 7A. As shown in FIG. 7B,device 700 has a curvature (as viewed from the plan view), whichadvantageously allows device 700 to conform to a user's gums during use.Device 700 has a first lobe 770 and a second lobe 772. During use ofdevice 700, first lobe 770 and second lobe 772 can apply pressure to theuser's superior labial artery, the Kiesselbach plexus, and/or thegreater palatine artery. First lobe 770 and second lobe 772 canindependently have a thickness “t” of about 2 mm to about 4 mm,alternatively about 1 mm to about 3 mm. In addition, a lower portion ofdevice 700 disposed below first lobe 770 and second lobe 772 can have athickness that is less than the thickness “t” of first lobe 770 and/orsecond lobe 772. For example, a lower portion of device 700 can have anaverage thickness of about 1 mm to about 4 mm. Apertures 740 traversethrough both the upper/thicker portion and the lower/thinner portion ofthe device 700.

In addition, a thickness “t” of the lobes (e.g., lobes 770 and/or 772)that is greater than a thickness of a lower portion of the device (e.g.,device 700) provides an opportunity for a user's lip to partiallycircumscribe device 700 during use allowing the lip to squeeze thedevice, further improving the grip on the device between the gums andlip of the user.

Materials

In some embodiments which may be combined with other embodiments, adevice of the present disclosure is made of a silicone, a latex, apolypropylene, a polyethylene, and combination(s) thereof. However,other materials are also contemplated. A device can be non-compressibleor slightly compressible, so that a device will substantially maintainits dimensions when inserted in the buccal cavity between the upper gumsand the upper lip.

In some embodiments which may be combined with other embodiments, adevice is made of a material that is configured to dissolve in thebuccal cavity of a user. Such material may include gelatinous sugar,such as those of candies or other foodstuffs. The material can betailored to provide the device with sufficient time to ameliorate theepistaxis while still being edible thereafter. In some embodiments,sugar granules can be disposed over a surface of a device of the presentdisclosure to provide additional grip to a user's lip and/or gums duringuse.

Other materials that may be used include oils, flavors, or medicines(such as acetaminophen, etc.)

Methods for Producing Devices

Devices of the present disclosure can be produced in various sizes,and/or with a trim-to-fit feature, to fit various users' mouths.Alternatively, a device may be custom-made to fit a user's mouth.

In some embodiments, a device of the present disclosure is made by amolding process. A device of the present disclosure can be made bymolding the device to correspond with the contours of a user's buccalcavity. Such a device may be made for a user that has particular needsregarding comfort or epistaxis issues that necessitate a custom fit.

In some embodiments, a device of the present disclosure is made by a3-dimensional printing process.

Methods for Using Devices

In some embodiments, methods of the present disclosure includeintroducing a device into a buccal cavity of a mouth of a user.Introducing can include introducing the device behind the user's upperlip and in front of the user's upper gums. Epistaxis can cease withinseconds of introducing a device of the present disclosure to the buccalcavity at a location behind the upper lip and in front of the upper gums(such that the gap of the device is disposed around (e.g., nested with)the user's frenulum). In some embodiments, epistaxis can cease withinabout 30 seconds or less, such as about 10 seconds or less, such asabout 5 seconds or less. In addition, use of a device of the presentdisclosure does not require medical training or knowledge in order tocease the epistaxis.

Overall, devices of the present disclosure having curvilinear sidewallshaving a plurality of protrusions and/or apertures providesnon-invasive, painless devices for treating (e.g., ceasing) epistaxis.Devices and methods of the present disclosure do not require continualpositional adjustment by the user, and the devices are substantially orentirely inconspicuous to outside observers during use by the user.Devices of the present disclosure provide a simply inserted oral devicewhich creates occlusion of the structures associated with anteriorepistaxis, occluding the flow of blood to the location of the hemorrhageresponsible for the epistaxis. In addition, protrusions and/or aperturesof devices of the present disclosure can provide (1) the device to stayin place while occluding flow of blood to a hemorrhage and (2)substantial or complete reduction in risk of a user inadvertentlyswallowing the device. In the event a device might be swallowed, devicesof the present disclosure may include one or more apertures such thatair can flow through the one or more apertures.

In addition, devices of the present disclosure can occlude a hemorrhageto stop anterior epistaxis without nasal packing, unlike a nasal tampon,leaving the nostril free from obstruction. Insertion and removal ofdevices of the present disclosure is painless, providing less fear for auser. In addition, risk of opening a clot upon removal of the device issubstantially less (e.g., eliminated), as compared to nasal tampons andballoon-like devices. In addition, devices of the present disclosure donot require substantial training on how to use the devices, as comparedto nasal tampons and balloon-like devices. In addition, devices of thepresent disclosure are small (e.g., as compared to devices having a stemor a bite tab) making the devices easy to transport without taking upsubstantial space (e.g., the devices can be transported in a user'spocket).

Additional Aspects

The present disclosure provides, among others, the following aspects,each of which may be considered as optionally including any alternateaspects.

Clause 1. A device for occluding epistaxis, the device comprising:

a first curvilinear wall, a second curvilinear wall, and a thirdcurvilinear wall each disposed at a top portion of the device, thedevice having an x-axis, y-axis, and z-axis, wherein the top portion isrelative to the y-axis;

a fourth wall and a fifth wall each disposed at a bottom portionrelative to the y-axis, the fourth wall and the fifth wall independentlyare substantially straight or curvilinear;

a first end comprising a front first end portion and a back first endportion, the first end is curvilinear corresponding to the firstcurvilinear wall, the first end disposed at an angle relative to thex-axis;

a second end comprising a front second end portion and a back second endportion, the second end is curvilinear and continuous with the thirdcurvilinear wall, the second end disposed at an angle relative to thex-axis;

a middle portion comprising a front middle portion and a back middleportion, the middle portion is curvilinear and continuous with thesecond curvilinear wall;

one or more protrusions having a substantially commensurate orientationrelative to the y-axis; and

one or more apertures disposed through the device.

Clause 2. The device of Clause 1, wherein the one or more protrusion isa plurality of protrusions, and each protrusion of the plurality ofprotrusions is independently disposed at an angle, relative to they-axis, of about 1° to about 10° or about −1° to about −10°.Clause 3. The device of Clauses 1 or 2, wherein:

a protrusion of the one or more protrusions extends from a peak point ofthe first curvilinear wall to a valley point of the fourth wall, and

the protrusion of the one or more protrusions is substantially parallelwith the y-axis.

Clause 4. The device of any of Clauses 1 to 3, wherein:

a second protrusion of the one or more protrusions extends from a peakpoint of the third curvilinear wall to a valley point of the fifth wall,and

the second protrusion of the one or more protrusions is substantiallyparallel with the y-axis.

Clause 5. The device of any of Clauses 1 to 4, wherein the one or moreprotrusions comprises about 10 protrusions to about 20 protrusions.

Clause 6. The device of any of Clauses 1 to 5, wherein:

the one or more protrusions is a plurality of protrusions;

a first portion of protrusions of the plurality of protrusions isdisposed at an angle of about 1° to about 10° relative to the y-axis;

a second portion of protrusions of the plurality of protrusions isdisposed at an angle of about −1° to about −10° relative to the y-axis;

a third portion of protrusions of the plurality of protrusions isdisposed at an angle of about 1° to about 10° relative to the y-axis;

a fourth portion of protrusions of the plurality of protrusions isdisposed at an angle of about −1° to about −10° relative to the y-axis;

the second portion is disposed between the first portion and the thirdportion; and

the third portion is disposed between the second portion and the fourthportion.

Clause 7. The device of any of Clauses 1 to 6, wherein the first end hasan end cap that has a wing-tipped shape and the second end has an endcap that has a wing-tipped shape.

Clause 8. The device of any of Clauses 1 to 7, wherein:

the one or more apertures is a plurality of apertures disposed as a rowacross a lower portion of the device, wherein the lower portion isrelative to the y-axis;

the first curvilinear wall forms a first lobe and the second curvilinearwall forms a second lobe; and

the first lobe and the second lobe have a thickness that is greater thana thickness of the lower portion of the device.

Clause 9. The device of any of Clauses 1 to 8, wherein the one or moreapertures is a plurality of apertures, the plurality of aperturescomprising about 10 apertures to about 20 apertures.

Clause 10. The device of any of Clauses 1 to 9, wherein the device has:

a width of about 50 mm to about 70 mm; and

a height of about 10 mm to about 18 mm.

Clause 11. The device of any of Clauses 1 to 10, wherein the one or moreapertures is a plurality of apertures disposed as a row in the middleportion of the device and is disposed along the y-axis.

Clause 12. The device of any of Clauses 1 to 11, wherein the rowcomprises about 2 apertures to about 4 apertures.

Clause 13. A device for occluding epistaxis, the device comprising:

a first curvilinear wall, a second curvilinear wall, and a thirdcurvilinear wall each disposed at a top portion of the device, thedevice having an x-axis, y-axis, and z-axis, wherein the top portion isrelative to the y-axis;

a fourth wall and a fifth wall each disposed at a bottom portion of thedevice, the fourth wall and the fifth wall independently aresubstantially straight or curvilinear;

a first end comprising a front first end portion and a back first endportion, the first end is curvilinear corresponding to the firstcurvilinear wall, the first end disposed at an angle relative to thex-axis;

a second end comprising a front second end portion and a back second endportion, the second end is curvilinear and continuous with the thirdcurvilinear wall, the second end disposed at an angle relative to thex-axis;

a middle portion comprising a front middle portion and a back middleportion, the middle portion is curvilinear and continuous with thesecond curvilinear wall; and

one or more apertures disposed through the device.

Clause 14. The device of Clause 13, wherein the one or more apertures isa plurality of apertures and each aperture of the plurality of aperturesis independently disposed at an angle, relative to the y-axis, of about1° to about 10° or about −1° to about −10°.Clause 15. The device of Clauses 13 or 14, wherein:

wherein the one or more apertures is a plurality of apertures,

an aperture of the plurality of apertures extends from a peak point ofthe first curvilinear wall to a valley point of the fourth wall, and

the aperture of the plurality of apertures is substantially parallelwith the y-axis.

Clause 16. The device of any of Clauses 13 to 15, wherein:

a second aperture of the plurality of apertures extends from a peakpoint of the third curvilinear wall to a valley point of the fifth wall,and

-   -   the second aperture of the plurality of apertures is        substantially parallel with the y-axis.        Clause 17. The device of any of Clauses 13 to 16, wherein the        one or more apertures is a plurality of apertures and the        plurality of apertures comprises about 10 apertures to about 20        apertures.        Clause 18. The device of any of Clauses 13 to 17, wherein:

the one or more apertures is a plurality of apertures,

a first portion of apertures of the plurality of apertures is disposedat an angle of about 1° to about 10° relative to the y-axis;

a second portion of apertures of the plurality of apertures is disposedat an angle of about −1° to about −10° relative to the y-axis;

a third portion of apertures of the plurality of apertures is disposedat an angle of about 1° to about 10° relative to the y-axis;

a fourth portion of apertures of the plurality of apertures is disposedat an angle of about −1° to about −10° relative to the y-axis;

the second portion is disposed between the first portion and the thirdportion; and

the third portion is disposed between the second portion and the fourthportion.

Clause 19. The device of any of Clauses 13 to 18, wherein the devicehas:

a width of about 50 mm to about 70 mm; and

a height of about 10 mm to about 18 mm.

Clause 20. A device for occluding epistaxis, the device comprising oneor more apertures.

As used herein, the terms “inner” and “outer”; “up” and “down”; “upper”and “lower”; “top” and “bottom”, “vertical” and “horizontal”, “upward”and “downward”; “above” and “below”; and other like terms as used hereinrefer to relative positions to one another and do not denote aparticular direction or spatial orientation of the overall device. Suchterms used herein are only used to reference a device (aspects of thedevice) to itself and such terms are not intended to refer to absoluteorientation of the device.

For the sake of brevity, only certain ranges are explicitly disclosedherein. However, ranges from any lower limit may be combined with anyupper limit to recite a range not explicitly recited, as well as, rangesfrom any lower limit may be combined with any other lower limit torecite a range not explicitly recited, in the same way, ranges from anyupper limit may be combined with any other upper limit to recite a rangenot explicitly recited. Additionally, within a range includes everypoint or individual value between its end points even though notexplicitly recited. Thus, every point or individual value may serve asits own lower or upper limit combined with any other point or individualvalue or any other lower or upper limit, to recite a range notexplicitly recited.

As is apparent from the foregoing general description and the specificembodiments, while forms of the present disclosure have been illustratedand described, various modifications can be made without departing fromthe spirit and scope of the present disclosure. Accordingly, the presentdisclosure is not limited thereby. Likewise whenever a composition, anelement or a group of elements is preceded with the transitional phrase“comprising,” it is further contemplated that the same composition orgroup of elements with transitional phrases “consisting essentially of”“consisting of,” “selected from the group of consisting of” or “is”preceding the recitation of the composition, element, or elements andvice versa may be used.

While the present disclosure has been described with respect to a numberof embodiments and examples, those skilled in the art, having benefit ofthis disclosure, will appreciate that other embodiments can be devisedwhich do not depart from the scope and spirit of the present disclosure.

What is claimed is:
 1. A device for occluding epistaxis, the device comprising: a first curvilinear wall, a second curvilinear wall, and a third curvilinear wall each disposed at a top portion of the device, the device having an x-axis, y-axis, and z-axis, wherein the top portion is relative to the y-axis; a fourth wall and a fifth wall each disposed at a bottom portion relative to the y-axis, the fourth wall and the fifth wall independently are substantially straight or curvilinear; a first end comprising a front first end portion and a back first end portion, the first end is curvilinear corresponding to the first curvilinear wall, the first end disposed at an angle relative to the x-axis; a second end comprising a front second end portion and a back second end portion, the second end is curvilinear and continuous with the third curvilinear wall, the second end disposed at an angle relative to the x-axis; a middle portion comprising a front middle portion and a back middle portion, the middle portion is curvilinear and continuous with the second curvilinear wall; a plurality of protrusions having a substantially commensurate orientation relative to the y-axis, wherein a first protrusion of the plurality of protrusions extends from a peak point of the first curvilinear wall to a valley point of the fourth wall, and the first protrusion of the plurality protrusions has a length that is substantially parallel with the y-axis, wherein a second protrusion of the plurality of protrusions extends from the first curvilinear wall to the fourth wall, and the second protrusion of the plurality of protrusions has a length that is substantially slanted with respect to the y-axis; and one or more apertures disposed through the device.
 2. The device of claim 1, wherein the plurality of protrusions is independently disposed at an angle, relative to the y-axis, of about 1° to about 10° or about −1° to about −10°.
 3. The device of claim 1, wherein: a third protrusion of the plurality of protrusions extends from a peak point of the third curvilinear wall to a valley point of the fifth wall, and the third protrusion of the plurality of protrusions is substantially parallel with the y-axis.
 4. The device of claim 1, wherein the plurality of protrusions comprises about 10 protrusions to about 20 protrusions.
 5. The device of claim 1, wherein the first end has an end cap that has a wing-tipped shape and the second end has an end cap that has a wing-tipped shape.
 6. The device of claim 1, wherein: the one or more apertures is a plurality of apertures disposed as a row across a lower portion of the device, wherein the lower portion is relative to the y-axis; the first curvilinear wall forms a first lobe and the second curvilinear wall forms a second lobe; and the first lobe and the second lobe have a thickness that is greater than a thickness of the lower portion of the device.
 7. The device of claim 1, wherein the one or more apertures is a plurality of apertures, the plurality of apertures comprising about 10 apertures to about 20 apertures.
 8. The device of claim 1, wherein the device has: a width of about 50 mm to about 70 mm; and a height of about 10 mm to about 18 mm.
 9. The device of claim 1, wherein the one or more apertures is a plurality of apertures disposed as a column in the middle portion of the device and is disposed along the y-axis.
 10. The device of claim 9, wherein the column comprises about 2 apertures to about 4 apertures.
 11. A device for occluding epistaxis, the device comprising: a first curvilinear wall, a second curvilinear wall, and a third curvilinear wall each disposed at a top portion of the device, the device having an x-axis, y-axis, and z-axis, wherein the top portion is relative to the y-axis; a fourth wall and a fifth wall each disposed at a bottom portion relative to the y-axis, the fourth wall and the fifth wall independently are substantially straight or curvilinear; a first end comprising a front first end portion and a back first end portion, the first end is curvilinear corresponding to the first curvilinear wall, the first end disposed at an angle relative to the x-axis; a second end comprising a front second end portion and a back second end portion, the second end is curvilinear and continuous with the third curvilinear wall, the second end disposed at an angle relative to the x-axis; a middle portion comprising a front middle portion and a back middle portion, the middle portion is curvilinear and continuous with the second curvilinear wall; a plurality of protrusions having a substantially commensurate orientation relative to the y-axis; and one or more apertures disposed through the device; a first protrusion of the plurality of protrusions is disposed at an angle of about 1° to about 10° relative to the y-axis; a second protrusion of the plurality of protrusions is disposed at an angle of about −1° to about −10° relative to the y-axis; a third protrusion of the plurality of protrusions is disposed at an angle of about 1° to about 10° relative to the y-axis; a fourth protrusion of the plurality of protrusions is disposed at an angle of about −1° to about −10° relative to the y-axis; the second protrusion is disposed between the first protrusion and the third protrusion; and the third protrusion is disposed between the second protrusion and the fourth protrusion.
 12. A device for occluding epistaxis, the device comprising: a first curvilinear wall, a second curvilinear wall, and a third curvilinear wall each disposed at a top portion of the device, the device having an x-axis, y-axis, and z-axis, wherein the top portion is relative to the y-axis; a fourth wall and a fifth wall each disposed at a bottom portion of the device, the fourth wall and the fifth wall independently are substantially straight or curvilinear; a first end comprising a front first end portion and a back first end portion, the first end is curvilinear corresponding to the first curvilinear wall, the first end disposed at an angle relative to the x-axis; a second end comprising a front second end portion and a back second end portion, the second end is curvilinear and continuous with the third curvilinear wall, the second end disposed at an angle relative to the x-axis; a middle portion comprising a front middle portion and a back middle portion, the middle portion is curvilinear and continuous with the second curvilinear wall; and a plurality of apertures disposed through the device, wherein a first aperture of the plurality of apertures extends from a peak point of the first curvilinear wall to a valley point of the fourth wall, and the first aperture of the plurality apertures has a length that is substantially parallel with the y-axis, wherein a second aperture of the plurality of apertures extends from the first curvilinear wall to the fourth wall, and the second aperture of the plurality of apertures has a length that is substantially slanted with respect to the y-axis.
 13. The device of claim 12, wherein the plurality of apertures is independently disposed at an angle, relative to the y-axis, of about 1° to about 10° or about −1° to about −10°.
 14. The device of claim 12, wherein: a third aperture of the plurality of apertures extends from a peak point of the third curvilinear wall to a valley point of the fifth wall, and the third aperture of the plurality of apertures is substantially parallel with the y-axis.
 15. The device of claim 12, wherein the plurality of apertures comprises about 10 apertures to about 20 apertures.
 16. The device of claim 12, wherein the device has: a width of about 50 mm to about 70 mm; and a height of about 10 mm to about 18 mm.
 17. A device for occluding epistaxis, the device comprising: a first curvilinear wall, a second curvilinear wall, and a third curvilinear wall each disposed at a top portion of the device, the device having an x-axis, y-axis, and z-axis, wherein the top portion is relative to the y-axis; a fourth wall and a fifth wall each disposed at a bottom portion of the device, the fourth wall and the fifth wall independently are substantially straight or curvilinear; a first end comprising a front first end portion and a back first end portion, the first end is curvilinear corresponding to the first curvilinear wall, the first end disposed at an angle relative to the x-axis; a second end comprising a front second end portion and a back second end portion, the second end is curvilinear and continuous with the third curvilinear wall, the second end disposed at an angle relative to the x-axis; a middle portion comprising a front middle portion and a back middle portion, the middle portion is curvilinear and continuous with the second curvilinear wall; and a plurality of apertures disposed through the device; a first aperture of the plurality of apertures is disposed at an angle of about 1° to about 10° relative to the y-axis; a second aperture of the plurality of apertures is disposed at an angle of about −1° to about −10° relative to the y-axis; a third aperture of the plurality of apertures is disposed at an angle of about 1° to about 10° relative to the y-axis; a fourth aperture of the plurality of apertures is disposed at an angle of about −1° to about −10° relative to the y-axis; the second aperture is disposed between the first aperture and the third aperture; and the third aperture is disposed between the second aperture and the fourth aperture. 